Dr. West on FDA Approval of Afatinib in NSCLC With Rare EGFR Mutations

H. Jack West, MD, thoracic oncologist, Swedish Cancer Institute of Swedish Medical Center, discusses the FDA approval of afatinib (Gilotrif) for the frontline treatment of patients with metastatic non—small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

The FDA approval for uncommon, non-resistance EGFR mutations was based on data of 32 patients in the phase II LUX-Lung 2 trial and the randomized phase III trials known as LUX-Lung 3 and LUX-Lung 6. The objective response rate with afatinib in these patients was 66% (95% CI, 47%-81%). Of those patients who responnded, 52% had duration of response lasting ≥12 months and 33% had response duration of ≥18 months.

Afatinib was initially approved by the FDA in 2013 for the treatment of patients with metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions. In 2016, this indication was expanded to include patients with squamous histology following progression on a platinum-based chemotherapy.